Enhacing TRANslational SAFEty Assessment through Integrative Knowledge Management


Start Date
End Date

IMI Funding
20 000 000
EFPIA in kind
19 490 899
Total Cost39 490 899


Assessing the safety of potential medicines remains immensely challenging. One major difficulty is understanding how well toxicity in animal tests predicts toxicity in humans. A lot of data on toxicity exists, but it is scattered across diverse public and private sources and stored in different formats.

The goal of the eTRANSAFE project is to develop a powerful data integration infrastructure (the Knowledge Hub) and use this as the basis for computer-based tools for use in drug development. The infrastructure would be flexible and expandable, and would draw on the latest technologies to deliver advanced solutions for data sharing, interoperability and exploitation. An ‘honest broker’ will ensure that confidential data would remain confidential, and overarching policies and guidelines will address ethical and legal issues such as the secondary use of human data. A large part of the project will be devoted to the creation of in silico (computer-based) tools for data mining and visualisation and, crucially, the prediction of potential toxicity.

The project outputs will increase the efficiency of preclinical toxicity studies, most notably in the pharmaceutical industry, and this in turn will help to speed up drug development. In addition, as the tools are computer-based, their use will contribute to a reduction in the use of animals in research. Finally, the project will contribute to the FAIR (‘findable, accessible, interoperable, re-useable) data principles.

Participants Show participants on map

EFPIA companies
  • AbbVie Inc., North Chicago, Illinois, United States
  • AstraZeneca AB, Södertälje, Sweden
  • Bayer Aktiengesellschaft, Leverkusen, Germany
  • Boehringer Ingelheim International GmbH, Ingelheim, Germany
  • Clarivate Analytics (Uk) Limited
  • F. Hoffmann-La Roche Ltd, Basel, Switzerland
  • Institut De Recherches Internationales Servier, Suresnes, France
  • Ipsen Innovation S.A.S., Les Ulis, France
  • Janssen Pharmaceutica NV, Beerse, Belgium
  • Merck KGaA, Darmstadt, Germany
  • Novartis Pharma AG, Basel, Switzerland
  • Sanofi-Aventis Deutschland GMBH, Frankfurt / Main, Germany
Universities, research organisations, public bodies, non-profit groups
  • Erasmus Universitair Medisch Centrum Rotterdam, Rotterdam, Netherlands
  • European Molecular Biology Laboratory, Heidelberg, Germany
  • Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V., München, Germany
  • Lhasa Limited, Leeds, United Kingdom
  • Liverpool John Moores University, Liverpool, United Kingdom
  • Simcyp Limited, London, United Kingdom
  • Universitat Pompeu Fabra, Barcelona, Spain
  • Universiteit Leiden, Leiden, Netherlands
  • Universität Wien, Vienna, Austria
Small and medium-sized enterprises (SMEs) and mid-sized companies (<€500 m turnover)
  • Molecular Networks GmbH – Computerchemie, Erlangen, Germany
  • Optibrium Limited
  • Pds Computer Software Limited
  • Synapse Research Management Partners S.L, Barcelona, Spain


Project coordinator
Ferran SANZ